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Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112397
Recruitment Status : Terminated (Decision to stop development of AZD1480)
First Posted : April 28, 2010
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):

Brief Summary:
This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.

Condition or disease Intervention/treatment Phase
Solid Malignancies Drug: AZD1480 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers With Lung Metastasis in the Expansion Phase.
Study Start Date : April 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: 1
AZD1480 until Maximum Tolerated Dose (MTD) is reached
Drug: AZD1480
continuous daily oral capsule

Experimental: 2
AZD1480 dose expansion of MTD
Drug: AZD1480
continuous daily oral capsule

Primary Outcome Measures :
  1. Safety and tolerability as assessed by Adverse events, vital signs, ECGs, Pulmonary Function Tests (DLco, FEV, FVC, Oxygen saturation) and laboratory data (chemistry, hematology and Urinalysis) [ Time Frame: Information will be collected from the time the informed consent is signed, throughout the study ]

Secondary Outcome Measures :
  1. Evaluation of the pharmacokinetics of AZD1480 [ Time Frame: During all cycles ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with advanced solid cancer without available therapy in the escalation phase and mutation positive NSCLC or non-smokers with other primary tumors lung metastasis in the expansion phase
  • ECOG Performance Status 0-1
  • Evidence of post-menopausal status in females or males willing to use barrier contraception

Exclusion Criteria:

  • Prior therapy with any JAK2 medications
  • Significant lung disorder or lung disease. Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. Evidence of significant pulmonary hypertension or COPD
  • Eye disease of the cornea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112397

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United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
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Study Chair: Gregory Curt, MD AstraZeneca
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Responsible Party: AstraZeneca Identifier: NCT01112397    
Other Study ID Numbers: D1060C00002
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013
Keywords provided by AstraZeneca:
jak 1
stat 3
Phase 1
Additional relevant MeSH terms:
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